CompletedPhase 3

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Finland, Netherlands, Norway171 participantsStarted 2002-12

Plain-language summary

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption To confirm general safety of 5 mg daily risedronate as compared to placebo

Who can participate

Age range45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ambulatory, healthy postmenopausal women with * Natural menopause and more than 5 years after their last menstrual period * or surgical menopause and more than 5 years after surgery * osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women). * With at least one risk factor for osteoporosis Exclusion Criteria: * Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

What they're measuring

Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Trial details

NCT IDNCT00353080

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-04

View on ClinicalTrials.gov More Osteoporosis, Postmenopausal trials